Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and tolerability of aln-app in patients with eoad

Conditions: Early-Onset Alzheimer Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (pd) and pharmacokinetics (pk) of a single dose and multiple doses of aln-app administered by intrathecal (it) injection in adult patients with early-onset alzheimer's disease (eoad). maximum treatment duration for part a: single dose. maximum treatment duration for part b: 12 months.


Eligibility criteria:
inclusion criteria: * has mild cognitive impairment or mild dementia due to eoad * has clinical dementia rating (cdr) global score 0.5 or 1.0 and mini mental state examination (mmse) \>20 exclusion criteria: * has non-alzheimer's disease dementia * has alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>2×upper limit of normal (uln) * has estimated glomerular filtration rate (egfr) \<45 ml/min/1.73m\^2 at screening * has recently received an investigational agent * has recent treatment with amyloid-targeting antibody note: other protocol defined inclusion / exclusion criteria apply

Keywords: eoad
the hepatitis c transplant collaborative

Conditions: Transplant; Failure, Heart; Hepatitis C

Summary: in this study we seek to test the hypothesis that safety and clinical outcomes after cardiac transplantation utilizing hcv nat+ donor organs as currently performed are acceptable.

organ offers from donors with prior or chronic hepatitis c virus (hcv) exposure have been historically underutilized for orthotopic heart transplantation because of the post-transplantation risks \[1, 2\]. the use of hcv antibody-positive (ab+) donors was associated with attenuated survival benefit after heart transplant and increased coronary allograft vasculopathy in the era before new highly effective direct-acting antiviral agents (daas) were developed \[3-5\]. these daas target multiple steps in the hcv replication life cycle \[6\]. newer, well-tolerated, oral direct-acting antivirals (daas) have recently been transforming thoracic transplant outcomes after donor-derived hcv transmission. moreover, now that hcv nucleic-acid testing (nat), a polymerase chain reaction (pcr)-based approach to detecting viral activity, is widely available and used on all us donor organs, transplant centers have more relevant information about the donor, allowing better risk assessments. as a result, the utilization of hcv nat+ donor hearts for transplantation is rapidly gaining momentum, with the obvious benefits of an enlarged donor pool \[7\]. appropriately, clinical safety trials are currently underway, including a multicenter effort led by the pi of this proposal. moreover, since the last \~2 years many transplant centers across the nation have started transplanting hcv nat+ donor organs as standard of care. we estimate that the number of hcv+ cardiac transplants is quickly outpacing the number of trial participants. hence, it is imperative that safety assessments and risk analyses 'catch up with the real world'.

Eligibility criteria:
inclusion criteria: 1. recipient of a proven hcv nat+ donor heart. 2. re-transplant patients will be included. exclusion criteria: 1. multi-organ transplantation
efficacy and safety of caz-avi in the treatment of infections due to carbapenem-resistant g- pathogens in chinese adults

Conditions: Urinary Tract Infection; Acute Pyelonephritis; Hospital Acquired Pneumonia; Ventilator-associated Pneumonia; Bacteremia; Intra-abdominal Infection

Summary: this is an open-label, randomized, multi-center, interventional, active-controlled phase 4 study to evaluate the efficacy and safety of caz-avi versus bat in the treatment of infected participants with selected infection types (hospital acquired pneumonia \[hap\] (including ventilator-associated pneumonia \[vap\]); complicated urinary-tract infection \[cuti\]; complicated intra-abdominal infection \[ciai\]; bloodstream infection \[bsi\]) due to carbapenem-resistant gram-negative pathogens in china.this study will be an estimation study. the statistical inference will be based on point estimate and confidence interval.


Eligibility criteria:
inclusion criteria: * male or female \>18 years of age * participant must have a diagnosis of an infection (hap/vap, cuti, ciai, bsi) due to confirmed carbapenem-resistant aerobic gram-negative pathogens, requiring administration of iv antibacterial therapy * participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy. * capable of giving signed informed consent exclusion criteria: * other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * participant is expected to require more than 21 days of treatment * participants who need more than 3 systemic antibiotics as part of best available treatment (bat) * previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). * participant is pregnant or breastfeeding. * acute physiology and chronic health evaluation (apache) ii score \>30 or \<10 using the most recent available data.
early nutritional intervention in patients with cancer

Conditions: Nutritional Intervention; Cancer; Malnutrition

Summary: the goal of this intervention study is to study the effect of nutritional interventions in patients with cancer receiving palliative chemotherapy. the main question it aims to answer is: does early nutritional interventions affect body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk and treatment tolerance in patients with cancer receiving palliative chemotherapy? researchers will compare patients receiving the intervention to a historical control cohort following current clinical practice.

background 30-50% of patients with cancer are malnourished, resulting in poorer prognosis, increased toxicities, reduced quality of life, and reduced physical function. nevertheless, cancer-related malnutrition remains largely unrecognized and undertreated in clinical practice. aim to examine the effect of an early individualised nutritional intervention on body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance in patients with cancer receiving palliative chemotherapy. methods an intervention study with a historical control cohort. participants are newly diagnosed patients with lung, pancreatic, ovarian, or colorectal cancers recruited at initiation of palliative chemotherapy. the control group followed current clinical practice. the intervention group receives an individualised nutritional intervention delivered by a clinical dietitian from treatment initiation and throughout the treatment trajectory. the intervention is tailored to the participant's nutritional needs, food preferences, nutrition impact symptoms, and smell- and taste disorders. the primary endpoint is change in body weight. secondary endpoints include quality of life, survival, muscle mass, performance status, physical function, nutritional risk, and treatment tolerance. data are collected at baseline and after 12 and 24 weeks. perspectives the project will provide new knowledge on the effects of individualised nutritional interventions for patients with cancer receiving palliative chemotherapy, and the potential to improve quality of life, treatment tolerance, and survival.

Eligibility criteria:
inclusion criteria: * patients who are newly diagnosed with lung, colorectal, ovarian, or pancreatic cancer. * patients treated with first-line palliative chemotherapy * patients who are danish speaking * patients ≥18 years of age * patients who are cognitive well-functioning exclusion criteria: * patients not using electronic mail * patients with dementia * patients not able to comply with the study protocol

Keywords: nutritional interventions dietetics cancer malnutrition nutrition
methadone in pediatric and adult sickle cell patients

Conditions: Sickle Cell Disease

Summary: to determine the pharmacokinetics of methadone in children and adults with scd who are experiencing a painful episode.


Eligibility criteria:
inclusion criteria: * greater than or equal to 7 years and less than or equal to 40 years * confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin c disease, and sickle-b thalassemia * currently experiencing a vaso-occlusive episode (voe), defined as acute pain in the extremities * admitted to the inpatient unit for further treatment * started on morphine patient controlled analgesia and infusion for pain management exclusion criteria: * diagnosis of acute chest syndrome * new focal neurologic findings or clinical concern of stroke * aplastic crisis with hemoglobin 2 g/dl below steady-state value * allergy to morphine or methadone * any other medical condition that the attending physician deems to be a contraindication to therapy * liver or renal insufficiency or failure, and congestive heart failure
silver diamine fluoride application on root caries fillings

Conditions: Root Caries

Summary: the goal of this clinical trial is to learn the influence of prior silver diamine fluoride (sdf) application on root caries fillings. the main questions to answer 1. compare the success of fillings placed in dental root decay that have prior sdf application and those without prior sdf application; 2. compare patient-based subjective evaluations on the two approaches mentioned above in treating root caries. participants will be allocated into two group 1. prior sdf application before receiving root caries fillings 2. directly receiving root caries fillings without any sdf application

the aim of the proposed study is to investigate the influence of prior sdf application on the restorative treatment of root caries. the objectives of the study are to 1. compare the success rate of restorations placed in root caries lesions that have prior sdf application and that of restorations placed without prior sdf application; 2. compare patient-based subjective evaluations on the two different approaches mentioned-above in treating root caries lesions. hypotheses to be tested: 1. prior sdf application increases the success rate of restorations placed in root caries; 2. patient-based subjective evaluations of the treatment outcomes are better when sdf is applied to the root caries lesions prior to restoring the lesions.

Eligibility criteria:
inclusion criteria: * older adults (aged 60 or above) * at least one untreated decayed dental root exclusion criteria: * no self-care ability for basic daily activities * teeth with severe decay (cannot be filled) * teeth indicated for extraction

Keywords: silver diamine fluoride older adults restorative treatment root caries
a clinical study: the antibacterial effect of insoluble antibacterial nanoparticles (iabn) incorporated in dental materials for root canal treatment

Conditions: Endodontic Treatment; Irreversible Pulpitis; Health Pulp; Infected Pulp

Summary: the effect of antibacterial nanoparticles, incorporated in root canal sealer material and in provisional restoration is going to be examined. two different tests are planned: (1) clinical and radiological evaluation of root canal sealer.(2) an evaluation in the laboratory the efficacy of provisional restoration during root canal treatment.we assume, based on our previous laboratory studies that show antibacterial properties, that the incorporation of the nanoparticels will improve the treatment outcome.

1. patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. after cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with (test group-40 patients) and without (control group- 40 patients) nanoparticles will seal the teeth between apointments. after a month the cotton wool will be taken out and tansferred to the laboratory. the root canal treatment will continue following the standard protocol. 2. patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. two study group (40 patients on each group) will have their canal sealed with a two types of endodontic sealers each + the nanoparticles. the control group (40 patients) will have their canal sealed with the conventional sealer alone. the patients will be invited to 4 follow ups: 2 weeks, 3 months, 6 months and 1 year during which a clinical and radiological examinations will be performed.while preparing the post, a small example of the sealer will be taken to a test in the lab.

Eligibility criteria:
inclusion criteria: 1. needs root canal treatment 2. for the provisional restoration- molar teeth with class ii restoration 3. for the provisional restoration-healty/ uninfected teeth 4. for the root canal sealer- single root canal 5. for root canal sealer-infected teeth exclusion criteria: 1. systemic health problems 2. pregnant women 3. the use of antiseptic mouth rinse or antibiotic up to 2 weeks before the beginning of study

Keywords: antibacterial polyethyleneimine nanoparticles quaternary ammonium dental endodotnic pulp bacteria root canal sealer temporary filling provisional restoration
a phase ii study of single agent mek162 in patients with advanced melanoma

Conditions: BRAF or NRAS Mutant Metastatic Melanoma

Summary: the study will assess the safety and efficacy of single-agent mek162 in adult patients with locally advanced and unresectable or metastatic malignant cutaneous melanoma, harboring brafv600e or nras mutations.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic cutaneous melanoma ajcc stage iiib to iv, not potentially curable with surgery * braf or nras mutation in tumor tissue * all patients enrolled should provide sufficient fresh or archival tumor sample at baseline to enable confirmation of braf or nras mutations and the additional analyses described in the protocol * evidence of measurable tumor disease as per recist * who performance status of 0-2 * adequate organ function and laboratory parameters exclusion criteria: * history or evidence of central serous retinopathy (csr), retinal vein occlusion (rvo) or any eye condition that would be considered a risk factor for csr or rvo * patients with unstable cns metastasis * prior treatment with a mek- inhibitor * impaired cardiovascular function * hiv, active hepatitis b, and/or active hepatitis c infection * pregnant or nursing (lactating) women * women of child-bearing potential unless they comply with protocol contraceptive requirements other protocol-defined inclusion/exclusion criteria may apply.

Keywords: metastatic melanoma, braf-mutant, nras-mutant
study of early-stage lung adenocarcinoma for early detection and effective treatment strategy

Conditions: Lung Adenocarcinoma

Summary: to determine the values of imaging and genetic biomarkers for prediction of tumor aggressiveness and prognosis in patient with early stage lung adenocarcinoma to identify unique copy number alteration in patient with early stage lung adenocarcinoma to evaluate the long-term change of ground-glass nodule combined with lung adenocarcinoma to suggest a guideline for planning an appropriate follow-up examination and management


Eligibility criteria:
inclusion criteria: * a. clinically and radiologically suspected lung adenocarcinoma * b. newly-diagnosed stage i or ii from the clinical work up including pet/ct * c. performance status of 0 to 1 on the ecog scale * d. age 20 years or older * e. able to tolerable dect imaging required by protocol * f. able to give study-specific informed consent exclusion criteria: * a. prior malignancy * b. planning of definitive rtx 나 neoadjuvant ccrtx * c. poor cardiopulmonary reserve

Keywords: lung adenocarcinoma prognosis tumor aggressiveness imaging biomarker genetic biomarker
the effect of education given to individuals with hypertension by mobile phone

Conditions: Hypertension; Mobile Education

Summary: this study was planned as randomized controlled trial in order to evaluate the effect of the mobile education given to the individuals with hypertension on dash diet compliance, healthy lifestyle behaviours, quality of life, mindfulness and stress levels. the study was conducted as a randomized controlled trial with 134 individuals with hypertension (68 experimental, 66 controlled) who applied a university hospital in edirne between the dates on 20.01.2022 and 18.05.2023. the data were collected by "patient information form", "healthy lifestyle behaviour scale ii", "eq-5d general quality of life scale", "mindful attention awareness scale" and "percieved stress scale" were used. an education application was installed on the mobile phones of the experimental group. individuals with hypertension were provided with a training for three months through the mobile application. data collection forms were filled in by the individuals with hypertension in the experimental and controlled groups at the beginning and at the 3rd month via the mobile application. the data were analyzed in spss 26 (statistical package for the social sciences) program with the shapiro-wilk test, student's t-test, paired-sample t-test, chi-square test, fisher's exact test, fisher-freeman-halton test and pearson correlation coefficient. the results were evaluated at % 95 confidence interval and the significance was evaluated at p\<0,05 level.


Eligibility criteria:
inclusion criteria: * those diagnosed with primary hypertension (at least 1 month ago), * over 18 years, * no communication barriers, * being literate, * volunteering to participate in the research, * individuals with hypertension who own a smartphone. exclusion criteria: * under 18 years old, * having a communication barrier, * those with chronic kidney disease, * individuals with hypertension and heart failure.
the impact of inflammatory adhesion on the prognosis of colon cancer patients

Conditions: Colon Cancer

Summary: the purpose of this study is to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients.

in some colon cancer patients, although adhesions between the tumor tissue and surrounding organs are found during surgery, postoperative pathology confirms that the tumor has not directly invaded the adhered organs; instead, the adhesions are caused by tumor-associated inflammation. this condition is defined as tumor-associated inflammatory adhesion. currently, the impact of tumor-associated inflammatory adhesion on patient prognosis is still unclear. this study aims to explore the impact of tumor-associated inflammatory adhesion on the prognosis of colon cancer patients through the surveillance, epidemiology, and end results (seer) and chinese multi-center databases.

Eligibility criteria:
inclusion criteria: 1. the patient was pathologically diagnosed as colon adenocarcinoma by endoscopic biopsy before operation. 2. all patients were considered to have tumors invading adjacent organs during surgery 3. all patients underwent radical surgery. exclusion criteria: 1. patients with distant metastasis, recurrent colon cancer and pt4b crc were excluded.

Keywords: colon cancer prognosis tumor-associated inflammatory adhesion
labor induction with misoprostol versus oxytocin in women with premature rupture of membranes

Conditions: Prelabor Rupture of Membranes; Premature Rupture of Membrane

Summary: this study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. it causes uterine contractions and ripening of the cervix. oxytocin sold under the brand name pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor. this randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. the primary outcome is the rate of vaginal delivery. secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Eligibility criteria:
inclusion criteria: * women in their 1st - 4th delivery * term prelabor rupture of membranes (37+0 to 42+0 gestational age) * vertex presentation * singleton pregnancy exclusion criteria: * multiple pregnancy * previous cesarean section * chorioamnionitis on admission * \>2 symptomatic uterine contractions in 10 minutes * prostaglandins hypersensitivity * contraindication for vaginal delivery

Keywords: prom
study of the fixation of various vectors in pet/ct in patients with a with lung cancer before and during of crt or rt

Conditions: Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung

Summary: study of the modification of the fixation(binding) of fluoro-2-deoxy-d-glucose (fdg), fluoro-misonidazole (fmiso) and 3'deoxy-3-fluoro-thymidine deoxy-3-fluoro-thymidine (flt) measured in tomography by broadcast(emission,issue) of positrons (pet) at patients before and in the course of exclusive radiotherapy or concomitant radiochemotherapy for primitive bronchial cancer. this protocle allows to study the simultaneous variations of the metabolism, the hypoxie and the cellular proliferation by pet scan at 5 patients reached(affected) by a primitive bronchial cancer in the course of exclusive radiotherapy for primitive bronchial cancer not small cell lung. the investigators are also going to study several scenarii of optimization of the radiotherapy according to the variations of the tumoral metabolism, the hypoxie and the cellular proliferation measured in the course of radiotherapy (theoretical study on console using the scanner and the various examinations).


Eligibility criteria:
inclusion criteria: * patients with non-small-cell lung carcinoma hitologicaly proved * candidate patients in a treatment with aim guardian by exclusive thoracic radiotherapy or of concomitant radiochemotherapy (tumoral dose superior to 60 gy) ( n=5 ). * measurable tumor according to the criteria of evaluation recist exclusion criteria: * histology other one than primitive bronchial cancer not in small cells lung * the patients for whom no tumoral target is assessable (forgiveness completes after first chemotherapy, operated patients). * patients for whom a radiotherapy with curative aim is not indicated (tumoral extension, metastases, general state, co-morbidity). * patient having benefited from an examination pet in the fdg with in more than 4 weeks and for which a new pet in the fdg is not necessary with in the framework of its disease

Keywords: positron-emission tomography pet scan fdg flt fmiso non-small-cell lung carcinoma chemo-radiation oncology suv